MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT MINI COMPLEX FILL; CNV DCS ORBIT (HCG)

Catalog Number 637MF0201

Device Problems Difficult To Position (1467); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

Information regarding patient age, weight and gender were not available.The lot number could not be provided; therefore, the manufacturing and expiration dates are unknown.(b)(4).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports being submitted for this complaint, with associated reference numbers of 1058196-2016-00004 and 1058196-2016-00005.

Event Description

As reported by a healthcare professional, during posterior communicating artery aneurysm coil embolization, the orbit galaxy coil (637mf0201/lot unknown) could not be shaped as expected, and after angle adjustment, resistance was felt during advancement.The coil was withdrawn with the prowler 14 microcatheter (catalog/lot unk) and the coil was found to be stretched.The microcatheter did not appear damaged.It was reported that the tumor neck exposure was not obvious and appeared ¿s-shaped.¿ the orbit galaxy was the fourth coil implanted, and a new coil was used to complete the procedure.The event did not result in disruption of blood flow, and the coil did not prematurely detach.The devices were prepped and used as per the ifu and a continuous flush had been maintained through the microcatheter.There was no report of patient injury and the event did not result in a clinically significant delay in the procedure.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Additional information was received on 01/29/2016: the catalog and lot number of the prowler 14 could not be obtained.There was no damage noted to the microcatheter during use.Product returned for analysis on 02/02/2016.Conclusion: as reported by a healthcare professional, during posterior communicating artery aneurysm coil embolization, the orbit galaxy coil (637mf0201/lot unknown) could not be shaped as expected, and after angle adjustment, resistance was felt during advancement.The coil was withdrawn with the prowler 14 microcatheter (catalog/lot unk) and the coil was found to be stretched.The microcatheter did not appear damaged.It was reported that the tumor neck exposure was not obvious and appeared ¿s-shaped¿.The orbit galaxy was the fourth coil implanted, and a new coil was used to complete the procedure.The event did not result in disruption of blood flow, and the coil did not prematurely detach.The devices were prepped and used as per the ifu and a continuous flush had been maintained through the microcatheter.There was no report of patient injury and the event did not result in a clinically significant delay in the procedure.A non-sterile orbit mini complex was received coiled inside of a plastic bag.The hypotube was inspected and several kinks were noted.The introducer was received zipped without damage.Part of the support coil was found outside of the introducer from the proximal end.The gripper and the embolic coil were found inside of the introducer.The gripper and the embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched.The od from the delivery tube was measured and was found within specification.Functional test could not be performed since part of the support coil were found outside of the introducer from the proximal end.The dhr review could not be performed since the lot number was not provided for evaluation.The coil stretching was confirmed.The cause of the stretched condition noted on the embolic coil was apparently caused by applying excessive force on the device, but it could not be conclusively determined.The coil positioning difficulty could not be evaluated, but it appears that aneurysm characteristics or the condition of the embolic coil (stretched) may have been a contributing factor.The resistance between the orbit galaxy and the prowler 14 microcatheter could not be evaluated due the several kinks noted on the hypotube, and since part of the support coil was found outside of the introducer from the proximal end.Controls are in place at the final assembly and packaging processes to detect coil stretching, and procedural factors appear to have contributed to the event.Neither the drh review nor the product analysis suggests that the failure experienced by the customer was related to the manufacturing process; therefore, no corrective actions will be taken at this time.This is 1 of 2 mdr reports being submitted for this complaint, with associated reference numbers of 1058196-2016-00004 and 1058196-2016-00005.

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 5350317
• MDR Text Key: 35262467
• Report Number: 1058196-2016-00004
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 637MF0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1